Associate Scientist, Biological Quality

Pfizer

Job Details

Under supervision, the **Associate Scientist** will be responsible for assessing and implementing Quality Control laboratory methods, SOPs and related documentation for remediation programs and method validation. Incumbent performs impact and gap assessments, organizes and summarizes laboratory documentation (e.g. specifications, procedures, reports, SOPs, etc.) and provides/executes recommended corrective actions (CAPAs). In addition, the associate scientist conducts investigations and corrections including: remediation, validation, transfer, verification, risk assessments and evaluation of Environmental and Microbiological Finished Product Data and associated change controls. The individual will be expected to develop collaborative relationships with the staff in each of the Business Units and the appropriate Quality representatives in order to facilitate continuous improvement of the applicable areas. The incumbent needs to have experience in Environmental Monitoring and/or Microbiological Finished Product Testing and a thorough working knowledge of the appropriate regulations.

The individual will be expected to have knowledge of LIMS (or equivalent system) and be able to identify trends and aberrant sample results. The individual will be responsible for writing/reviewing site sample rationales, method development documents, and microbiological protocols.

The Associate Scientist will be required to complete reports within the required timeframes. Protocols, documents, and reports may be presented to representatives from regulatory agencies, therefore a thorough understanding of all regulatory requirements among multiple agencies a critical aspect of this role.

+ Ability to effectively collaborate with others to achieve team goals and expectations.

+ Must be familiar with laboratory systems such as LIMs, TrackWise.

+ Must be familiar with cGMP.

+ Must be able to work independently and in a team environment.

+ Prior trending experience preferred.

+ Must be able to effectively present and communicate findings from completed trending.

**PHYSICAL/MENTAL REQUIREMENTS**

Use computer terminal and work within a Biological Safety Cabinet and/or Laminar Flow Hood for extended periods of time

**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Overtime and weekend work is required as needed. Occasional travel may be required.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.